Dr. Reddy's Laboratories and Its U.S. Subsidiary, Promius Pharma,
Announce FDA Approval for TOSYMRA™ (Sumatriptan Nasal Spray) 10 mg, in
the U.S. Market

January 27, 2019 11:53 PM Eastern Standard Time

HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and
its subsidiary, Promius Pharma, LLC today announced the approval of
TOSYMRA (previously known as DFN-02) by the U.S. Food and Drug
Administration (FDA). TOSYMRA is indicated for the acute treatment of
migraine with or without aura in adults. TOSYMRA is the latest product
to join the Promius Pharma acute migraine treatment portfolio. The
company is working toward commercialization of this product.

“We are excited about the approval of TOSYMRA. This approval affirms our
ability to develop well-differentiated products to meet the unmet needs
of patients with migraine and HCPs treating them,” said G.V. Prasad,
Co-Chairman and CEO, Dr. Reddy’s Laboratories.

According to Dr. Anil Namboodiripad, PhD, President, Promius Pharma,
“TOSYMRA nasal spray is formulated using a proprietary novel excipient
known as Intravail® to achieve blood levels similar to a 4-mg
sumatriptan subcutaneous injection, resulting in rapid onset of action.
Independent research shows that 26% to 40% of migraine patients are not
optimally controlled with their current treatment.1 For
patients who suffer from the debilitating and disruptive effects of
migraine, there continues to be a need for reliable and efficacious
treatment options. At Promius, we are committed to developing new ways
of improving patient experiences. TOSYMRA is a mist-like nasal spray
that acts rapidly and is well tolerated.”

Important Patient Safety Information:

What important information should I know about TOSYMRA?

TOSYMRA can cause serious side effects, including: heart attack and
other heart problems, which may lead to death. Stop using TOSYMRA and
get emergency medical help right away if you have any of the following
symptoms of a heart attack:

discomfort in the center of your chest that lasts for more than a few
minutes, or that goes away and comes back

TOSYMRA is not for people with risk factors for heart disease (high
blood pressure, high cholesterol levels, smoking, overweight, diabetes,
family history of heart disease) unless a heart exam is done and shows
no problem.

hemiplegic migraines or basilar migraines. If you are not sure if you
have these, ask your healthcare provider

had a stroke, transient ischemic attacks (TIAs), or problems with your
blood circulation

taken any of the following medicines in the last 24 hours:
almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan,
ergotamines, or dihydroergotamine. Ask your healthcare provider if you
are not sure if your medicine is listed above

are taking certain antidepressants, known as monoamine oxidase (MAO)-A
inhibitors or it has been 2 weeks or less since you stopped taking a
MAO-A inhibitor. Ask your healthcare provider or pharmacist for a list
of these medicines if you are not sure.

an allergy to sumatriptan or any of the ingredients in TOSYMRA.

What should I tell my healthcare provider before taking TOSYMRA?

Tell your healthcare provider about all of your medical conditions, and
about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while using TOSYMRA?

TOSYMRA can cause dizziness, weakness, or drowsiness. If you have these
symptoms, do not drive a car, use machinery, or do anything where you
need to be alert.

What are possible side effects of TOSYMRA?

TOSYMRA may cause serious side effects including:

changes in color or sensation in your fingers and toes (Raynaud’s
syndrome)

problems with blood circulation to your legs and feet (peripheral
vascular ischemia). Symptoms of peripheral vascular ischemia include:
cramping and pain in your legs or hips, feeling of heaviness or
tightness in your leg muscles, burning or aching pain in your feet or
toes while resting, numbness, tingling, or weakness in your legs, cold
feeling or color changes in 1 or both legs or feet

Increased blood pressure including a sudden severe increase
(hypertensive crisis) even if you have no history of high blood
pressure

medication overuse headaches. Some people who use too much migraine
medicine, such as TOSYMRA, for 10 or more days each month may have
worse headaches (medication overuse headache). If your headaches get
worse, your healthcare provider may decide to stop your treatment with
TOSYMRA.

serotonin syndrome. Serotonin syndrome is a rare but serious problem
that can happen in people using TOSYMRA, especially if TOSYMRA is used
with anti-depressant medicines called SSRIs or SNRIs.

Call your healthcare provider right away if you have any of the
following: symptoms of serotonin syndrome: mental
changes such as seeing things that are not there (hallucinations),
agitation, or coma; fast heartbeat; changes in blood pressure;
high body temperature; tight muscles; or trouble walking

hives (itchy bumps); swelling of your tongue, mouth, or throat

seizures have happened in people taking sumatriptan who have never had
seizures before

The most common side effects of TOSYMRA include tingling,
dizziness, feeling warm or hot, burning feeling, feeling of heaviness,
feeling of pressure, flushing, feeling of tightness, numbness,
application site (nasal) reactions, abnormal taste, and throat
irritation.

Tell your healthcare provider if you have any side effect that bothers
you or that does not go away. These are not all the possible side
effects of TOSYMRA. For more information, ask your healthcare provider
or pharmacist.

You are encouraged to report negative side effects of prescription
drugs. To report SUSPECTED SIDE EFFECTS, call Promius Pharma at
1-888-966-8766 or contact the FDA at 1-800-FDA-1088 (1-800-332-1088) or
online at http://www.fda.gov/Safety/MedWatch.

Please see Patient Information, Instructions for Use and Full
Prescribing Information for TOSYMRA.

What is TOSYMRA used for?

TOSYMRA is a prescription medicine used to treat acute migraine
headaches with or without aura in adults.

TOSYMRA is not used to treat other types of headaches such as hemiplegic
(that make you unable to move on one side of your body) or basilar (rare
form of migraine with aura) migraines. TOSYMRA is not used to treat
cluster headaches.

TOSYMRA is not used to prevent or decrease the number of migraines you
have.

It is not known if TOSYMRA is safe and effective in children under 18
years of age.

About Intravail®

Intravail® is a registered trademark of Neurelis, Inc.
Intravail® drug delivery technology enables the non-invasive
delivery of a broad range of protein, peptide and non-peptide drugs (up
to 30,000 daltons in size) that can currently only be administered by
injection. Intravail® can be utilized via the oral, buccal,
dermal, and intranasal routes of drug administration.

Reference: 1. Pavlovic JM, Buse DC, Reed ML, et al. Triptan use
and discontinuation among a population sample of persons with migraine:
Results from Migraine in America Symptoms and Treatment (MAST) Study.
Presented at: 60th Annual Scientific Meeting of the American Headache
Society®; June 28, 2018; San Francisco, CA.

Promius Pharma is a wholly-owned subsidiary of Dr. Reddy’s Laboratories,
one of the largest and most respected pharmaceutical companies in the
world. With a robust commercial infrastructure and extensive research
and development capabilities through its parent company, Promius Pharma
is committed to bringing new products to market that meet patients’
needs in dermatology and neurology. For more information, visit www.promiuspharma.com.

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